SESSION TITLE: Pulmonary Arterial Hypertension Posters II
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: Progression of pulmonary arterial hypertension (PAH) adversely affects patients’ quality of life (QoL), yet no clinical trials have evaluated, as a primary endpoint, patient assessments of the effects of pharmacologic treatment on PAH progression. The MOTION study is designed to quantify multiple patient-reported outcomes (PROs) in treatment-naïve PAH patients treated with riociguat, a direct stimulator of soluble guanylate cyclase approved for the treatment of PAH. As an exploratory analysis, the trial will also investigate whether a new telemetric device (Accelerator band, FitBit®) is a valid method for measuring exercise capacity, usually assessed in PAH trials with the 6-minute walk test (6MWT).
METHODS: The MOTION study is a prospective, multicenter, single-arm, open-label, phase IV, 24-week trial designed to assess whether riociguat monotherapy will result in improved PROs among treatment-naïve PAH patients. Following a screening period of up to 14 days, patients will receive therapy with riociguat during a 10-week titration phase and will be maintained on their individual optimized dose for an additional 14 weeks.
RESULTS: The primary endpoint is patient-reported change from baseline to week 24 on the Living With Pulmonary Hypertension (LPH) questionnaire. Secondary endpoints include LPH at week 16, and change from baseline to weeks 16 and 24 in the Work Limitations Questionnaire short form, the SF-12, the Borg Dyspnea Index, 6-minute walk distance, and World Health Organization functional class. Accelerator activity recorded by the FitBit® device during the 6MWT will be collected at screening, baseline (visit 1), and at weeks 16 (visit 8) and 24 (visit 10). This study is ongoing.
CONCLUSIONS: The MOTION study is expected to provide insights into the impact PAH treatment with riociguat may have on patients’ QoL. It is also the first PAH study to investigate the usefulness of Accelerator band technology as a means to gather data on patients’ exercise capacity and function during the 6MWT.
CLINICAL IMPLICATIONS: Patient-reported outcomes and/or Accelerator technology may allow for routine assessment of clinical status in a real-world, home-based setting.
DISCLOSURE: Stephen Mathai: Consultant fee, speaker bureau, advisory committee, etc.: Bayer Healthcare, Consultant fee, speaker bureau, advisory committee, etc.: Actelion Pharmaceuticals, Grant monies (from sources other than industry): Pulmonary Hypertension Association Omar Minai: Consultant fee, speaker bureau, advisory committee, etc.: Bayer Healthcare, Consultant fee, speaker bureau, advisory committee, etc.: Actelion, Consultant fee, speaker bureau, advisory committee, etc.: Gilead David Platt: Employee: Bayer Healthcare Gerald O'Brien: Employee: Bayer Healthcare Carol Satler: Employee: Bayer Healthcare The following authors have nothing to disclose: Sean Sullivan, Debra Lerner, Deborah Levine
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